Recall Z-0331-2027 ยท LRO General Surgery Tray
AVID Medical, Inc.
Halyard MINOR PACK. Model/Catalog Number: VASF105-08.
| Date | Nov 3, 2026 (initiated Sep 8, 2026) |
| Status | Open, Classified |
| Reason | Potential for open seals on header bags, compromising sterility. |
| Root cause | Process control |
| Action | AVID Medical notified consignees on about 09/08/2026 via emailed "URGENT: MEDICAL DEVICE CORRECTION" letter. Consignees were instructed to Segregate, Quarantine, and Inspect all kits identified. If the header bag seal appears to be compromised, discard the entire kit. Consignees were also requested to complete and return the provided Recall Response Form. Distributors were instructed to notify customers if affected kits were further distributed. On 10/06/2026 AVID Medical sent an updated "URGENT: MEDICAL DEVICE CORRECTION" letter to consignees via email. The strategy was updated and consigne |
| Quantity | 108 kits |
| Distribution | U.S Nationwide distributor in the state of Illinois. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.